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Therapeutic Class Overview Topical Immunomodulators

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Therapeutic Class Overview Topical Immunomodulators Therapeutic Class Overview Topical Immunomodulators Therapeutic Class • Overview/Summary: This review encompasses the topical immunomodulators agents used in atopic dermatitis (eczema). The two medications included in this therapeutic class are Elidel® (pimecrolimus) and Protopic® (tacrolimus).1,2 The mechanism of action of these medications are not known, however, it has been demonstrated that both agents inhibit the phosphatase activity of calcineurin. Inhibition of calcineurin inhibits the transcription of cytokines involved in T-cell activation. Hence, these agents are referred to as calcineurin inhibitors. In addition, both agents have been shown to prevent the release of inflammatory cytokines and mediators from mast cells stimulated by antigen/immunoglobulin E. Both agents are Food and Drug Administration (FDA) approved as second-line therapy for the short- term and non-continuous chronic treatment of atopic dermatitis in non immunocompromised adults and children. Pimecrolimus 1% cream is approved for mild-moderate atopic dermatitis for patients two years of age and older while tacrolimus is approved for treatment of moderate to severe atopic dermatitis.1,2 Consensus guidelines recommends topical corticosteroids as the standard of care for the management of atopic dermatitis.3-6 Topical immunomodulators are considered to be an alternative to topical corticosteroids and should only be utilized if the patient is intolerant to or has failed conventional topical corticosteroid therapy. Concerns regarding the long-term safety of these agents have been addressed in the treatment guidelines and position papers published by medical associations. On January 19, 2006, the FDA approved updated labeling for the topical immunomodulators, pimecrolimus and tacrolimus.7,8 This updated labeling was a result of cancer-related adverse events with the use of these medications, however position statements from several professional organizations have noted the lack of conclusive evidence linking an increase incidence of malignancies to the topical calcineurin inhibitors.9-11 Table 1. Current Medications Available in the Therapeutic Class1,2,12 Generic Food and Drug Administration Approved Dosage Generic (Trade Name) Indications Form/Strength Availability Pimecrolimus Second-line therapy for short-term and Cream: (Elidel®) noncontinuous chronic treatment of mild to 1% moderate atopic dermatitis in nonimmunocompromised patients two years of age - and older who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable Tacrolimus Second-line therapy for the short-term and Ointment: (Protopic®) noncontinuous chronic treatment of moderate to 0.03% severe atopic dermatitis in nonimmunocompromised 0.1% adults and children who have failed to respond - adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable Evidence-based Medicine • The topical calcineurin inhibitors, pimecrolimus and tacrolimus are Food and Drug Administration (FDA) approved for the treatment of atopic dermatitis. • These agents are available as pimecrolimus 1% cream (Elidel®) and tacrolimus 0.03 and 0.1% ointment (Protopic®). Page 1 of 3 Copyright 2013 • Review Completed on 7/28/2013 Therapeutic Class Overview: topical immunomodulators • Current guidelines for the treatment of atopic dermatitis recommend the use of topical corticosteroids as first line treatment and recommend the use of topical pimecrolimus or tacrolimus in those patients intolerant or unresponsive to corticosteroids or in whom corticosteroids are contraindicated.3-6 • Concerns regarding the long-term safety of these agents have been addressed by the Public Health Advisory, the American College of Asthma, Allergy, and Immunology, the American Academy of Allergy, Asthma, and Immunology, the European Dermatology Forum, and the Canadian Society of Allergy and Clinical Immunology in position statements supporting the safety of these agents when used according to product labeling.9-11 • Clinical studies have demonstrated these two agents to be effective in treatment of atopic dermatitis compared to placebo. Compared to medium and high potency corticosteroids tacrolimus was found to be equivalent while pimecrolimus was found to be less effective compared to potent corticosteroids.18- 25 • Limited head-to-head studies and meta-analyses comparing the efficacy of the calcineurin inhibitors have been conducted, with results favoring efficacy of tacrolimus over pimecrolimus and similar adverse effects between the groups were similar.13-17 Key Points within the Medication Class • According to Current Clinical Guidelines:3-6 o Topical immunomodulators are to be used as second line therapy following failure or contraindication to topical corticosteroids. o Topical immunomodulators due not cause atrophy of the skin like prolonged topical corticosteroids use and may be used on body parts where atrophy is a concern or where a potent-very-high potent topical corticosteroid is not appropriate. • Other Key Facts: o There are no generic agents in the class. o Safety concerns regarding long-term use, particularly updated with cancer-related adverse events with the use of these medications forced updates to product labeling to include black box warnings7-8 . Position statements from several professional organizations have noted the lack of conclusive evidence linking an increase incidence of malignancies to the topical calcineurin inhibitors.9-11 o Limited direct clinical trials between agents favor tacrolimus in efficacy in both adult and pediatric patients. 13-17 . Majority of trials showed that the two agents were comparable in adverse effects. o Pimecrolimus is approved for mild-moderate atopic dermatitis for patients two years of age and older.1 Tacrolimus is approved in children and adults with moderate-severe atopic dermatitis. o 2 o Dosing frequency and route of administration vary between products. References 1. Elidel® [package insert]. East Hanover, NJ: Novartis; 2011 Jun. 2. Protopic® [package insert]. Deerfield, IL: Astellas Pharma; 2012 May. 3. Hanifin JM, Cooper KD, Ho VC, Kang S, Krafchik BR, Margolis DJ, et al. Guidelines of care for atopic dermatitis. J Am Acad Dermatol. 2004 Mar;50(3):391-404. 4. Schneider L, Tilles S, Lio P, Boguniewicz M, Beck L, LeBovidge et al. Atopic dermatitis: a practice parameter update 2012. J Allergy Clin Immunol. 2013 Feb;131(2):295-9.e1-27. 5. Primary Care Dermatology Society and British Association of Dermatologists. Guidelines for the management of atopic eczema. Available at: http://www.bad.org.uk/Portals/_Bad/Guidelines/Clinical%20Guidelines/PCDS- BAD%20Eczema%20reviewed%202010.pdf.Accessed on: July 29, 2013. 6. Ring J, Alomar A, Bieber T, Deleuran M, Fink-Wagner A, Gelmetti C, et al. European Dermatology Forum (EDF); European Academy of Dermatology and Venereology (EADV); European Federation of Allergy (EFA); European Task Force on Atopic Dermatitis (ETFAD); European Society of Pediatric Dermatology (ESPD); Global Allergy and Asthma European Network (GA2LEN). Guidelines for treatment of atopic eczema (atopic dermatitis) part I. J Eur Acad Dermatol Venereol. 2012 Aug;26(8):1045-60. 7. FDA Alert for Healthcare Professionals: Pimecrolimus (marketed as Elidel) Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm153525.htm. Accessed on 08/03/10. Page 2 of 3 Copyright 2013 • Review Completed on 07/28/2013 Therapeutic Class Overview: topical immunomodulators 8. FDA Alert for Healthcare Professionals: Tacrolimus (marketed as Protopic). Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126497.htm. Accessed on 08/03/10. 9. Fonacier L, Spergel J, Charlesworth EN, Weldon D, Beltrani V, Bernhisel-Broadbent J, et al. Report of the topical calcineurin inhibitor task force of the American College of Allergy, Asthma, and Immunology and the American Academy of Allergy, Asthma, and Immunology. J Allergy Clin Immunol. 2005;115(6):1249-53. 10. Ring J, Barker J, Behrendt H, Braathen L, Darsow U, Dubertret L, et al. Review of the potential photo-carcinogenicity of topical calcineurin inhibitors: position statement of the European Dermatology Forum. J Eur Acad Dermatol Venereol. 2005;19(6):663- 71. 11. Segal AO, Ellis AK, Kim HL. CSACI position statement: safety of topical calcineurin inhibitors in the management of atopic dermatitis in children and adults. Allergy Asthma Clin Immunol. 2013 Jul 9;9(1):24. 12. Drug Facts and Comparisons [database on the Internet]. St. Louis: Wolters Kluwer Health, Inc.; 2013 [cited 2013 Jul]. Available from: http://online.factsandcomparisons.com. 13. Paller AS, Lebwohl M, Fleischer AB Jr, Antaya R, Langley RG, Kirsner RS, et al. Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in the treatment of atopic dermatitis: results from 3 randomized, comparative studies. J Am Acad Dermatol. 2005;52(5):810-22. 14. Kirsner RS, Heffernan MP, Antaya R. Safety and efficacy of tacrolimus ointment vs pimecrolimus cream in the treatment of patients with atopic dermatitis previously treated with corticosteroids. Acta Derm Venereol. 2010;90:58-64. 15. Yin Z, Xu J, Luo D. Efficacy and tolerance of tacrolimus and pimecrolimus for atopic dermatitis: a meta-analysis. J Biomed Res. 2011 Nov;25(6):385-91. 16. Fleischer Jr AB, Abramovits W, Breneman D, Jaracz E. Tacrolimus ointment is more effective than pimecrolimus cream
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